The University of Texas Medical Branch Sr. Clinical Research Coordinator- Department of Surgery in Galveston, Texas
Min Qualifications Bachelor's degree and five years experience as clinical research coordinator or equivalent experience. JOB DESCRIPTION: The Senior Clinical Research Coordinator manages clinical research projects for Principal Investigators by gathering patient data via methods specified in the study protocol. Provides complex administrative duties in support of the study to insure compliance with regulations. Salary Range
Specific Job Related Duties
- Applies knowledge in contributing to Good Clinical Practice (GCP) activities and/or other regulatory activities.
- Under the direction of the PI, supervises and assists with the preparation and submission of all IRB and Regulatory Documents to obtain final approval and may draft various communications with Sponsor.
- Attends and participates in the Investigator meeting.
- Reviews goals and requirements of any new protocols and coordinates study initiation.
- Identifies and recruits clinical research subjects for participation of studies, collects data, and monitors enrollment goals.
- Schedules and participates in protocol initiation visits.
- Develops assessment tool per protocol to use in clinical research and teaches research team and hospital personnel how to use the assessment tool as allowed per medical practice.
- Develops procedures for laboratory collection and storage.
- Maintains accurate source documentation and appropriate forms as per protocol including participant records, drug documentation, reconciling study drug accountability; monitors documentation for quality and accuracy.
- Responsible for entering data in various sponsor databases.
- Responsible for interacting with sponsors throughout the study, including monitoring visits.
- Handle subject-related duties in the OR and clinic as required.
- Conducts reviews of on-going studies and oversees quality assurance on ongoing protocols; productive working relationship with the study monitor.
- Precepts new clinical research staff and educates research staff regarding scientific aspects of studies.
- Provides performance management for staff under direction of PI.
- Assesses communication process within Department and/or services required by the protocol.
- Elicits relevant data from sources outside of the hospital.
- Assists PI in budget development; may monitor ledgers.
- Assists in processing and shipping lab specimens efficiently and cost effectively; retrieves and/or sends identified research specimens certified if indicated as per regulations; maintains supply inventory and equipment; ensures return of test article /clinical supplies; maintains regulatory standards.
- Identifies and recruits clinical research subjects; monitors enrollment goals and modifies recruitment strategies, as necessary; mentors all clinical research personnel regarding enrollment/recruitment.
- Monitors participants labs and notifies the PI of laboratory findings.
- Monitors medical records for adverse events and other reportable events.
- Serves as a role model and resource for the clinical research staff.
- May assist PI in obtaining Informed Consent from study participant and documents appropriately.
- Able to work independently.
- Adheres to internal controls established for department.
Equal Employment Opportunity UTMB Health strives to provide equal opportunity employment without regard to race, color, national origin, sex, age, religion, disability, sexual orientation, gender identity or expression, genetic information or veteran status. As a VEVRAA Federal Contractor, UTMB Health takes affirmative action to hire and advance women, minorities, protected veterans and individuals with disabilities.
Full/Part Time: Full-Time
Job Type: Regular
Job Title: Sr. Clinical Research Coordinator- Department of Surgery
Job ID: 61821
Business Unit: SOMED